Elastomeric closures are commonly used to seal various sterile medical containers currently in use, such as vials and flexible solution bags. For example, elastomeric stoppers are used to close small volume unit dose glass vials. Likewise elastomeric reseals are used to close the ports of flexible plastic containers such as IV solution bags.
The elastomeric closures described above permit access into the sealed container only by penetrating the elastomeric closure. Conventionally, the elastomeric closures have thick dimensions to withstand sterilization and shelf storage. The resiliency of the elastomer and the thick dimensions requires a sharp or pointed entry device such as a syringe needle or a piercing pin to penetrate the closures. The elastomeric closure reseals after the entry device is withdrawn, potentially permitting multiple entries.
The majority of medical stoppers and reseals currently in use are molded of medical grade elastomeric compounds in a thickness that does not allow easy penetration by any entry device other than a sharp or pointed device. Thus the material and configuration (i.e. thickness) of conventional elastomeric closures requires use of a sharp or pointed entry device to gain access to the sealed container.
With increasing concern about diseases such as HIV and AIDS, which are carried by bodily fluids, the use of "sharp" devices in the healthcare environment is being minimized. Sharps have the potential to breach the skin barrier by an "accidental stick" and thereby potentially transmit disease. It is estimated that more than one half of the sharps currently used in hospitals are used only for fluid transfer and connection involving IV administration sets. These sharp "connectors" can be replaced by blunt cannula and pre-pierced reseals such as the Lifeshield.RTM. Blunt Cannula and the Lifeshield.RTM. Prepierced Reseal, both sold by Abbott Laboratories.
However, when withdrawing a solution or drug from a vial with a sharp needle syringe, the user must exercise care. The majority of elastomeric closures for drug or solution vials currently in use cannot be readily pierced by a blunt entry devices such as the LifeShield.RTM. Blunt Cannula. Thus, sharp needles remain in use.
Recent concerns about drug effects due to accidental sticks has led to the desire to reduce the need for healthcare providers to use sharp needles for access to drug vials. Vial adapters have been introduced to shield the healthcare provider from the sharp cannula which penetrates the vial. The other end of the cannula may include a standard luer connector for fluid communication with a syringe barrel having a compatible luer connector. Alternatively, as disclosed in U.S. Pat. No. 5,100,394 to Dunbar, et al titled, "Pre-Slit Injection Site", the opposite end of the cannula may include a pre-slit septurn compatible with a blunt cannula entry device. However, healthcare providers are reluctant to use the available vial adapters since the adapters increase the time for set-up and change-over, created additional waste material for disposal and added additional expense.
Thus, it is an object of the present invention to provide a pointed adapter that is compatible with blunt entry devices for fluid access through thick elastomeric closures such as vial stoppers.
It is another object of the present invention to provide an adapter which is economical to manufacture and easy to use.
It is another object of the present invention to provide an adapter which indicates previous use.
Another object of the present invention is to provide an adapter which does not require undue force by the health care provider to insert the blunt entry device, while still protecting the user from accidental stick and the adapter from touch contamination.
Other important objects of the present invention will become readily apparent from the following description and drawings.